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Pilot Study to Evaluate Ear Acupressure Effects in Treating Seasonal Allergic Rhinitis

This study has been terminated.
(Target enrollment not met within specific time period.)
Sponsor:
Information provided by (Responsible Party):
Gailen D. Marshall Jr., MD PhD, University of Mississippi Medical Center
ClinicalTrials.gov Identifier:
NCT01921348
First received: August 8, 2013
Last updated: May 23, 2017
Last verified: May 2017
  Purpose
We hypothesize that ear acupressure will be effective in treating seasonal allergic rhinitis by changing the immune parameters and the psychological impact factors are associated with ear acupressure treatment outcome.

Condition Intervention
Seasonal Allergic Rhinitis Device: acupressure pellets

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: Pilot Study to Evaluate Ear Acupressure Effects in Treating Seasonal Allergic Rhinitis

Resource links provided by NLM:


Further study details as provided by Gailen D. Marshall Jr., MD PhD, University of Mississippi Medical Center:

Primary Outcome Measures:
  • Rhinoconjunctivitis Quality of Life Questionnaire (Nasal Symptoms Domain Only) [ Time Frame: 8 weeks ]

    RQLQ is an instrument that has 28 items in 7 domains (sleep, non-rhinoconjuctivitis symptoms, practical problems, nasal symptoms, eye symptoms activity limitations and emotional function). Participants are asked to recall impairments experienced during the previous week and to respond to each item on a 7-point scale (0=no impairment; 6=maximum impairment).

    In this protocol, we used the nasal symptoms domain only; 4 questions, total scale ranges from 0 minimum to 24 maximum.

    Longitudinal changes of nasal symptoms domain total were reported from baseline to 8 weeks.



Secondary Outcome Measures:
  • Psychological Measures [ Time Frame: 8 weeks ]
    Effects of ear acupressure on immune biomarkers based upon psychological differences including perceived stress, anxiety, depression and worry.


Other Outcome Measures:
  • Immune Biomarkers [ Time Frame: 8 weeks ]
    Changes in Regulatory T(Treg), Type 1 Regulatory T (Tr1), T helper 3(TH3), T helper 1(TH1), T helper 2(TH2)cells, salivary cortisol, alpha amylase, Interferon gamma(IFNg), Interleukin 4(IL4) and Interleukin 10(IL10) cytokine production from baseline to 8 weeks.


Enrollment: 18
Study Start Date: August 2013
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
34 participants will be randomized to wear acupressure pellets in the designated acupressure points and apply pressure as instructed by the study personnel.
Device: acupressure pellets
The treatment group will have acupressure pellets placed in pre-determined acupressure point on the ear that relates to rhinitis.
Other Name: Magrain Ion Pellets
Sham Comparator: Sham
33 participants will be randomized to wear acupressure pellets in non-specific areas of the ear and apply pressure as instructed by the study personnel.
Device: acupressure pellets
The sham group will have acupressure pellets placed in a pre-determined non-specific acupressure point on the ear that is not related to rhinitis.
Other Name: Magrain Ion Pellets

Detailed Description:
The purpose of the study is to investigate the clinical potential of ear acupressure in treating seasonal allergic rhinitis. We hypothesize that ear acupressure will be effective in treating seasonal allergic rhinitis by changing the immune parameters and the psychological impact factors such as expectation, stress, depression, and anxiety can moderate the ear acupressure treatment effectiveness in allergic rhinitis by influencing the immune parameters.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Seasonal allergic rhinitis was diagnosed both by history and clinical examination and by the presence at positive skin prick tests
  • All participants need to have at least 2 years of seasonal allergic rhinitis symptoms and a positive skin prick test to one or more pollen allergens

Exclusion Criteria:

  • use of systemic corticosteroids within past 3 months period,
  • active asthma,
  • hearing aid usage,
  • history of adhesive tape allergy,
  • history of metal allergy,
  • HIV,
  • hepatitis B or C,
  • history of hematologic, autoimmune, or malignant disease,
  • pregnancy or lactation,
  • ear acupressure (EAP) or acupuncture for respiratory disease within the last 6 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01921348

Locations
United States, Mississippi
University of Mississippi Medical Center - Allergy, Immunology and Asthma Care Clinic
Jackson, Mississippi, United States, 39216
Sponsors and Collaborators
University of Mississippi Medical Center
Investigators
Principal Investigator: Gailen D Marshall, MD, PhD University of Mississippi Medical Center
  More Information

Publications:
Zheng MF, Lin C, Zheng LP, He FR, Effects of acupuncture-moxibustion on monocyte Th1/Th2 cytokine in peripheral blood of patients with perennial allergic rhinitis, Journal of Acupuncture and Tuina Science 2010;8:85-88

Responsible Party: Gailen D. Marshall Jr., MD PhD, Professor of Medicine and Pediatrics, Vice Chair for Research, Department of Medicine, Director, Division of Clinical Immunology and Allergy, Chief, Laboratory of Behavioral Immunology Research, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT01921348     History of Changes
Other Study ID Numbers: 2013-0165
Study First Received: August 8, 2013
Results First Received: March 6, 2017
Last Updated: May 23, 2017

Keywords provided by Gailen D. Marshall Jr., MD PhD, University of Mississippi Medical Center:
Hay Fever
Hayfever
Pollen Allergy
Pollinosis
Seasonal Allergic Rhinitis

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on June 27, 2017